medical MODERATE Updated 2017-02-15

Physio-Control, Inc. recalls LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option.

See all recalls from Physio-Control, Inc. →

Recalled Product

LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: LOT NUMBERS OF AFFECTED MODULE: Lot # 1520 and 1544. SERIAL NUMBERS OF DEVICES: 32877820, 34356891, 35984435, 37223110, 37440401, 37456675, and 37913307.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for LIFEPAK 12 Defibrillator/Monitor with →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

Related medical Recalls

Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-0027/16;

2026-03-18 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-0027/12;

2026-03-18 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-8521/11;

2026-03-18 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Instrumentation Laboratory recalls GEM Premier 5000 PAK; Part No. 00055407504.

2026-03-18 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.